Gut Microbiota Changes of HIV Patients Before and After One Year of ART

HIV Infections Clinical Trial

Official title:

Effect of 1-year Antiretroviral Treatment on Gut Microbiota Diversity and Composition in Treatment-naïve HIV-infected Chinese Individuals

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04297501
• Other study ID #: CACTGUT18A
• Status: Completed
• Start date: March 1, 2018
• Est. completion date: December 31, 2019

Study information

• Verified date: February 2018
• Source: Peking Union Medical College Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

HIV infection leads to destruction of CD4+T cells in the gut-associated lymphoid tissue (GALT) and promotes a decline in mechanical barrier functions of the gut mucosa, and the subsequent translocation of microbial products from the gastrointestinal tract to systemic circulation. The gut mucosal immune system is not completely restored by cART, and the resultant microbial translocation may contribute to chronic inflammation, inadequate CD4 T-cell recovery, and increased rates of serious non-AIDS events. Many studies have revealed strong and characteristic compositional differences in gut microbiota between individuals with HIV infection and seronegative controls. So far, several probiotic organisms have shown the ability to enhance intestinal epithelial barrier functions, reduce inflammation, and support effective Th-1 responses. Probiotics mainly stimulates polymeric IgA secretion, avoid bacterial overgrowth and their translocation, and produce a self-limited inflammatory response through development of regulatory T (Treg) cells by anti-inflammatory cytokine production. Therefore, we design a prospective, randomized, double-blind, placebo-controlled study to determine whether the use of a probiotic can expand beneficial microbiota that aid in decreasing bacterial translocation and pro-inflammatory cytokine production, thereby improving immune functions in HIV-infected subjects. Participants in the intervention group will receive oral probiotic containing 3 billion Bifidobacterium and 1 billion Lactobacillus once daily, while those in the placebo group will take placebo which contains no probiotic but has the same flavor and characteristics as the probiotic product.. Gut bacterial community diversity and composition, immune recovery and activation in peripheral plasma, plasma levels of gut damage, microbial translocation and inflammation at baseline and after 12 months of receiving intervention will be analyzed.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: December 31, 2019
• Est. primary completion date: December 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• 18-65 years old;

• Documented HIV infection;

• No history of gastrointestinal diseases;

• Good adherence and promise to follow-up;

• Ability to provide informed consent.

Exclusion Criteria:

• Administration of antibiotics, probiotics, or prebiotics or experience of diarrhea within the previous 3 months;

• Administration of anti-inflammatory drugs, corticosteroids, immunosuppressive drugs, immunomodulator within the previous 3 months;

• Severe organ dysfunction;

• Pregnancy or breastfeeding.

Related Conditions & MeSH terms

• HIV Infections

Intervention

Drug:
• Antiretroviral Therapy
All participants receive antiretroviral therapy to control virus replication and restore CD4+ T-cell count.

Locations

Country	Name	City	State
China	Peking Union Medical College Hospital	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking Union Medical College Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Gut bacterial community diversity and composition	Microbiota profiling are performed on fecal samples from each subjects, and 8-10 participants receive gastrointestinal endoscope according to their willingness	Change from baseline to 1 year after antiretroviral therapy
Secondary	Absolute CD4+ T-cell and CD8+ T-cell counts in peripheral plasma	CD4+ and CD8+ T cells are analyzed by flow cytometry	Change from baseline to 1 year after antiretroviral therapy
Secondary	The level of T cell activation and different immunophenotype in peripheral plasma	CD38+HLA-DR+, CD8+CD28+ T cell subsets are analyzed by flow cytometry	Change from baseline to 1 year after antiretroviral therapy
Secondary	Plasma levels of inflammation and coagulation markers	Levels of IL-8, IL-1ß, IL-6, CRP, TNF-a and D-dimer	Change from baseline to 1 year after antiretroviral therapy
Secondary	Plasma levels of microbial translocation and monocyte activation markers	Levels of I-FABP, LPS, LBP, sCD14, sCD40L, and IDO	Change from baseline to 1 year after antiretroviral therapy
Secondary	Metabolic measurements from blood plasma	Levels of vitamin D, glucose and insulin, and lipid profiling	Change from baseline to 1 year after antiretroviral therapy
Secondary	Feasibility, safety, tolerability, adherence, and acceptability of study product and procedures	Based on patients' description and intervention-related adverse events	Change from baseline to 1 year after antiretroviral therapy
Secondary	HIV RNA	HIV-RNA is detected by Roche assay with the limit of 20 copies/mL	Change from baseline to 1 year after antiretroviral therapy